Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities

NCT07530640 | Recruiting Phase 3

• 2 other identifiers: Statins study in acute KD2024ZZ2041
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the safety and effects of atorvastatin in treatment of Chinese Kawasaki disease (KD) children complicated with coronary artery abnormalities (CAA) in acute phase. The main questions it aims to answer are: Is atorvastatin safe in Chinese children of acute KD? Does atorvastatin contribute to control the acute inflammation in KD and improve the CAA?

Conditions

Kawasaki Disease; Coronary Artery Abnormalities

Keywords

Kawasaki Disease; Coronary artery abnormalities; Atorvastatin; Acute

Outcome Measures

Primary Outcomes (1)

• Incidence of statin-associated side effects in Chinese acute KD children with CAA

  Safety evaluation of atorvastatin in acute KD children, referring to the incidence of statin-associated side effects (SASE). SASE include statin-associated clinical adverse events, elevated transaminase, creatine kinase, blood glucose and hypocholesterolemia.

  Before, 2 weeks and 6 weeks after taking atorvastatin

Secondary Outcomes (8)

• Change of levels of high-sensitivity C reactive protein (sCRP)

  Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin

• Change of levels of serum amyloid A(SAA)

  Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin

• Change of levels of interleukin-6 (IL-6)

  Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin

• Change of levels of NT-proBNP

  Before, 2 weeks and 6 weeks after taking atorvastatin

• Change of levels of albumin

  Before, 1 week, 2 weeks and 6 weeks after taking atorvastatin

Study Arms (4)

statin group-level 1

EXPERIMENTAL

Participants will receive atorvastatin of dose level 1 (0.15 mg/kg/day) for 6 weeks on the basis of conventional therapy.

Drug: atorvastatin of dose level 1

statin group-level 2

EXPERIMENTAL

Participants will receive atorvastatin of dose level 2 (0.25 mg/kg/day) for 6 weeks on the basis of conventional therapy.

Drug: atorvastatin of dose level 2

statin group-level 3

EXPERIMENTAL

Participants will receive atorvastatin of dose level 3 (0.4 mg/kg/day) for 6 weeks on the basis of conventional therapy.

Drug: atorvastatin of dose level 3

Control group

NO INTERVENTION

Participants will only receive conventional therapy.

Interventions

atorvastatin of dose level 2 DRUG

The study is to be designed as dose-escalation protocol and enroll a minimum of 3 subjects per dose level (level 1, 0.15 mg/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).

statin group-level 2

atorvastatin of dose level 3 DRUG

The study is to be designed as dose-escalation protocol and enroll a minimum of 3 subjects per dose level (level 1, 0.15 mg/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).

statin group-level 3

atorvastatin of dose level 1 DRUG

The study is to be designed as dose-escalation protocol and enroll a minimum of 3 subjects per dose level (level 1, 0.15 mg/kg/day; level 2, 0.25 mg/kg/day; level 3, 0.4 mg/kg/day). Participants will take atorvastatin for 6 weeks. The dose-limiting toxicities (DLTs) are used to determine the maximum tolerated dose (MTD).

statin group-level 1

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• KD complicated with CAA, less than 20 days after the onset of KD, or more than 20 days after onset but the KD inflammation has not been controled.
• IVIG and/or other anti-inflammatory treatments have been used/are being used.
• The guardians agree to atorvastatin treatment and sign the informed consent form.

You may not qualify if:

• Patients with history of family hypercholesterolemia/taking statins/severe chronic diseases.
• Patients with abnormal laboratory data including CK≥500U/L, total cholesterol\<3.1mmol/L, ALT or AST≥ 2 times the upper limit of normal.
• The guardians do not agree to atorvastatin treatment.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

RECRUITING

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chen Chu, MD

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Chen Chu, MD

CONTACT

+86 21 64932026; chickenchu@163.com

Fang Liu, MD

CONTACT

+86 21 64932800; liufang@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 15, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)